Sr. Project Manager

Job Title Sr. Project Manager Location San Diego, CA (Travel to site required; remote work may be considered as the project progresses) Duration 12 Months Employment Type Contract on W2 (US Citizens or Green Card holders only) Client Medical Device Company Role: Senior Project Manager - Operations LOCAL CANDIDATES ONLY! Senior Project Manager – Operations Responsibilities Initiate, plan and drive multiple projects throughout the project lifecycle. Ensure continuity of Program Management methodologies, records, reports, metrics, and program communications. Lead reviews and remediate material management, manufacturing and distribution processes and practices. Collaborate and support program initiation. Drive projects through planning, execution and close‑out phases. Establish project governance and metrics for success. Communicate project status with teams, peers, and leadership. Manage project budgets. Proactively manage risks and issues, taking corrective action. Balance resources to manage interdependencies based on business priorities. Perform other related duties as assigned by manager. Qualifications 7-10 years of direct experience managing multiple complex projects. Experience working in a highly regulated industry (medical device, pharmaceutical) with hands‑on experience in a manufacturing environment. Experience leading master validation activities (IQ/OQ/PQ, TMV) and implementing procedures for traceability and change control; knowledge of statistical techniques. Experience authoring, reviewing and executing qualification and validation protocols. Knowledgeable of medical device quality systems, FDA, and applicable ISO standards (ISO 13485, ISO 14971, EU MDR). Experience leading virtual teams. Experience with problem‑solving methodologies. Knowledgeable of 21CFR 820, ISO 13485, ISO 14971, EU MDR. Demonstrated knowledge of budgeting and resource allocation. Strong leadership and management skills in a matrix organization. Excellent communication skills at all levels. Problem‑solving skills; trained in Lean Six Sigma, Kaizen, or other methodologies. Business acumen and ability to align program achievements with organizational success. Education Technical or business bachelor’s degree required, or equivalent work experience. Skills & Certifications DFSS, Six Sigma, Lean Six Sigma Green Belt Certified. PMP Certified. Location & Travel Travel to site in San Diego, CA is required. Remote work may be considered as the project progresses. #J-18808-Ljbffr